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Human Insulin - N (Novolin)

Trade Name : Novolin

Novo Nordisk

INJECTION, SUSPENSION

Strength 100 [iU]/mL

INSULIN HUMAN

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Human Insulin - N (Novolin) which is also known as Novolin and Manufactured by Novo Nordisk. It is available in strength of 100 [iU]/mL per ml. Read more

Human Insulin - N (Novolin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Dosage and Administration ()-------------------------------------11/2019
  • Warnings and Precautions ()---------------------------------------11/2019
  • NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
  • NOVOLIN N is an intermediate-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. ()
  • No data
  • Injectable suspension: NOVOLIN N 100 units per mL(U-100) is available as:
  • NOVOLIN N is contraindicated:
  • No data
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen:
  • Hypoglycemia:
  • Hypoglycemia Due to Medication Errors:
  • Hypersensitivity Reactions:
  • Hypokalemia:
  • Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs)
  • The following adverse reactions are also discussed elsewhere in the labeling:
  • Adverse reactions observed with NOVOLIN N include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain and edema. ()
  • Table 1: Clinically Significant Drug Interactions with NOVOLIN N
  • Drugs that may increase the risk of hypoglycemia:
  • Drugs that may decrease the blood glucose lowering effect:n- Arrayn- )
  • Drugs that may increase or decrease the blood glucose lowering effect:
  • Drugs that may blunt the signs and symptoms of hypoglycemia:
  • No data
  • Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment can be treated with intramuscular or subcutaneous glucagon or intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately .
  • NOVOLIN N (isophane insulin human suspension) is an intermediate-acting human insulin. It is a polypeptide hormone structurally identical to native human insulin and is produced by recombinant DNA technology, utilizing (bakeru2019s yeast) as the production organism. NOVOLIN N has the empirical formula CHNOS and a molecular weight of 5808.
  • Figure 1: Structural formula of human insulin
  • NOVOLIN N is a sterile, white and cloudy suspension that contains isophane insulin human suspension (NPH) for subcutaneous use, 100 units/mL. It also contains glycerol 16 mg/mL, metacresol 1.5 mg/mL, zinc approximately 33.5 mcg/mL (vial), zinc approximately 33.2 mcg/mL (FlexPen), phenol 0.65 mg/mL, disodium phosphate dihydrate 2.4 mg/mL, protamine sulfate approximately 0.35 mg/mL and water for injection. The pH is adjusted to 7.1 to 7.5. Hydrochloric acid 2N and sodium hydroxide 2N are added to adjust pH.
  • No data
  • Carcinogenicity and fertility studies were not performed in animals.
  • Human insulin is not mutagenic in the following tests: The chromosomal aberration assay in human lymphocytes, the micronucleus assay in mouse polychromatic erythrocytes, and the mutation frequency assay in Chinese hamster cells.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Never Share a NOVOLIN N FlexPen or Syringe between Patients
  • Array
  • Advise patients using NOVOLIN N vials or NOVOLIN N FlexPen not to share needles, syringes, or FlexPen with another person. Sharing poses a risk for transmission of blood-borne pathogens .
  • Hyperglycemia or Hypoglycemia
  • Array
  • Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of NOVOLIN N therapy. Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia .
  • Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.
  • Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision .
  • Hypoglycemia due to Medication Errors
  • Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products .
  • Hypersensitivity Reactions
  • Advise patients that hypersensitivity reactions have occurred with NOVOLIN N. Inform patients on the symptoms of hypersensitivity reactions and to seek medical attention if they occur .
  • Novolin, FlexPen and Novo Nordisk are registered trademarks of Novo Nordisk A/S.
  • ReliOn is a registered trademark of Wal-Mart Stores, Inc. and is used under license by Novo Nordisk Inc.
  • Patent Information: http://novonordisk-us.com/patients/products/product-patents.html
  • u00a9 2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • ReliOnbrand manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • For Wal-Mart Stores Inc.
  • For information about NOVOLIN N contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, NJ 08536
  • 1-800-727-6500
  • Patient Information
  • NOVOLIN N (No-voe-lin)
  • (isophane insulin human suspension) for subcutaneous use
  • Do not share your Novolin N FlexPen or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
  • What is Novolin N?
  • Novolin N is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.
  • Who should not use Novolin N?
  • Do not use Novolin N if you:
  • Before using Novolin N, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all of the medicines you take,
  • Before you start using Novolin N, talk to your healthcare provider about low blood sugar and how ton- manage it.
  • How should I use Novolin N?
  • Keep Novolin N and all medicines out of the reach of children.
  • Your dose of Novolin N may need to change because of:
  • u25cf change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet,
  • or because of other medicines you take.
  • What should I avoid while using Novolin N?
  • While using Novolin Nn
  • What are the possible side effects of Novolin N?
  • Novolin N may cause serious side effects that can lead to death, including:
  • Treatment with TZDs and Novolin N may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
  • These are not all of the possible side effects of Novolin N. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • General information about the safe and effective use of Novolin N
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. use Novolin N for a condition for which it was not prescribed. give Novolin N to other people, even if they have the same symptoms you have. It may harm them.
  • This Patient Information leaflet summarizes the most important information about Novolin N. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Novolin N that is written for healthcare providers.
  • For more information, call 1-800-727-6500 or visit .
  • What are the ingredients in Novolin N?
  • Active ingredient:
  • Inactive ingredients: n- ,
  • Novolin FlexPen and Novo Nordisk are registered trademarks of Novo Nordisk A/S.
  • u00a9 2005 u2013 2019 Novo Nordisk
  • Manufactured by:
  • Novo Nordisk A/S
  • DK-2880 Bagsvaerd, Denmark
  • For information about Novolin N contact:
  • Novo Nordisk Inc.
  • 800 Scudders Mill Road
  • Plainsboro, New Jersey 08536
  • 1-800-727-6500
  • Patient Instructions for Use
  • Novolin N 10 mL multiple-dose vial (100 Units/mL, U-100)
  • Before starting, gather all of the supplies that you will need to use for preparing and giving your insulin injection.
  • Never re-use syringes and needles.
  • How should I use the Novolin N vial?
  • How should I mix Novolin N with Regular Human insulin?
  • Different insulins should be mixed only under instruction from a healthcare provider. Novolin N should be mixed only when injections with syringes are used.u00a0 Insulin syringes may vary in the amount of space between the bottom line and the needle (u201cdead spaceu201d), so if you are mixing two types of insulin be sure to discuss any change in the model and brand of syringe you are using with your healthcare provider. Novolin N can be mixed with Regular human insulin right before use. When you are mixing Novolin N insulin with Regular human insulin, always draw the Regular human (clear) insulin into the syringe first.
  • How should I store Novolin N?
  • Revised: 11/2019
  • Instructions For Use
  • Novolin N FlexPenn
  • (isophane insulin human suspension) for subcutaneous use
  • Introduction
  • Please read the following instructions carefully before using your Novolin N FlexPen.
  • Do not share your Novolin N FlexPen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
  • Novolin N FlexPen is a disposable, single-patient-use, dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. Novolin N FlexPen is designed to be used with NovoFine, NovoFine Plus or NovoTwist needles.
  • People who are blind or have vision problems should not use Novolin N FlexPen without help from a person trained to use Novolin N FlexPen.
  • Getting ready
  • Make sure you have the following items:
  • Preparing your Novolin N FlexPen
  • Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. Novolin N should look white and cloudy after mixing.
  • A
  • Pull off the pen cap (see diagram A).
  • Bn- 1n- 2
  • Repeat moving the pen until the liquid appears white and cloudy. use the pen if the liquid appears discolored or contains particles.
  • For every following injectionn- 1n- 2
  • After mixing, complete all the following steps of the injection right away. If there is a delay, the insulin will need to be mixed again.
  • evenly mixed. If there are less than 12 units left in your Novolin N FlexPen, use a new pen.
  • Wipe the rubber stopper with an alcohol swab.
  • Attaching the needle
  • C.
  • Screw the needle tightly onto your Novolin N FlexPen. It is important that the needle is put on straight (see diagram C).
  • Never place a disposable needle on your Novolin N FlexPen until you are ready to take your injection.
  • D
  • E
  • your needles with other people. You may give other people a serious infection, or get a serious infection from them.
  • never put the inner needle cap back on the needle
  • Giving the airshot before each injection
  • Before each injection small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to make sure you take the right dose of insulin:
  • F
  • G.
  • H.
  • A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.
  • If you do not see a drop of insulin after 6 times, do not use the Novolin N FlexPen and contact Novo Nordisk at 1-800-727-6500.
  • A small air bubble may remain at the needle tip, but it will not be injected.
  • Selecting your dose
  • Check and make sure that the dose selector is set at 0.
  • I.
  • The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer (see diagram I). When turning the dose selector, be careful not to press the push-button as insulin will come out.
  • You cannot select a dose larger than the number of units left in the cartridge.
  • You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear.
  • Giving the injection
  • Give the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting. Wipe the skin with an alcohol swab and let the area dry.
  • Novolin N can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs (thighs), or upper arms.
  • Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.n use the same injection site for each injection. inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
  • J
  • Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram J). Be careful only to push the button when injecting.
  • Turning the dose selector will not inject insulin.
  • K
  • You may see a drop of insulin at the needle tip. This is normal and has no effect on the dose you just received. If blood appears after you take the needle out of your skin, press the injection site lightly with a gauze pad or an alcohol swab. n
  • After the injection
  • Do not recap the needle.
  • If you do not have a sharps container, carefully slip the needle into the outer needle cap. Safely remove the needle and throw it away as soon as you can.
  • L.
  • Maintenance
  • For the safe and proper use of your Novolin N FlexPen be sure to handle it with care. Avoid dropping your Novolin N FlexPen as it may damage it. If you are concerned that your Novolin N FlexPen is damaged, use a new one. You can clean the outside of your Novolin N FlexPen by wiping it with a damp cloth. Do not soak or wash your Novolin N FlexPen as it may damage it. Do not refill your Novolin N FlexPen.
  • insulin, and will help to make sure you inject the right dose of insulin for future injections.
  • Do not
  • or get a serious infection from them.
  • Nordisk.
  • damaged.
  • get too hot or too cold.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • Issued: 11/2019
  • NDC n
  • Novolinn n- N
  • NPH (isophane insulin
  • human suspension)
  • 100 units/mL
  • 10 mL multi-dose vial
  • Novo Nordiskn
  • NDC n
  • Novolinu00ae N
  • Array
  • NPH (isophane insulin
  • human suspension)
  • 100 units/mL
  • 10 mL multi-dose vial
  • ReliOnn
  • NDC 0169-3004-15
  • List 300415
  • Novolin
  • FlexPenn
  • NPH
  • (isophane insulin human suspension)
  • 100 units/mL (U-100)
  • For Single Patient Use Only
  • 5u00d73 mL Prefilled Pens
  • For subcutaneous use only
  • Recommended for use with NovoFine,
  • NovoFine Plus or NovoTwist disposable needles.
  • Until first use: Keep in a cold place.
  • Store at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F).
  • Do not freeze.
  • In-use: Keep at room temperature below 30u00b0C (86u00b0F). Protect from light.
  • Dispense in this sealed carton.
  • Shake carefully before using.
  • See enclosed insert for proper technique.
  • N
  • novo nordiskn
  • NDC 0169-3004-25
  • List 300425
  • Novolin
  • FlexPenn
  • NPH
  • (isophane insulin human suspension)
  • 100 units/mL (U-100)
  • For Single Patient Use Only
  • 5u00d73 mL Prefilled Pens
  • For subcutaneous use only
  • Recommended for use with NovoFine,
  • NovoFine Plus or NovoTwist disposable needles.
  • Until first use: Keep in a cold place.
  • Store at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F).
  • Do not freeze.
  • In-use: Keep at room temperature below 30u00b0C (86u00b0F). Protect from light.
  • Dispense in this sealed carton.
  • Shake carefully before using.
  • See enclosed insert for proper technique.
  • ONLY FOR RETAIL SALE BY
  • WALMART AND ITS AFFILIATES
  • N
  • ReliOnn

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